BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3923613 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02511
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT OF CLIP ASSEMBLY MASHED ONTO BUSHING. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ON TO THE BUSHING AND COULD NOT BE DEPLOYED. THE PRONGS WERE BENT, WOULD NOT OPEN OR CLOSE, AND WERE NOT LOCKED IN TO THE CAPSULE. IT WAS ALSO NOTED THAT THE OVER SHEATH HAD A TEAR AT THE DISTAL END. PRODUCT ANALYSIS CONFIRMS THE REPORTED EVENT; HOWEVER, INVESTIGATION ALSO FOUND THE CLIP ASSEMBLY MASHED ON TO THE BUSHING, THE CLIP WOULD NOT RELEASE FROM THE CATHETER, WITH CLIP ARMS/PRONGS BENT AND THE SHEATH DETACHED. GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT OPEN AND CLOSE. ANOTHER RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT: CLIP ASSEMBLY MASHED ONTO THE BUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400464 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522600 ML000565C3

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR